Osteomesh PC12(39,10,1)Recalls & reported problems
Osteopore International Pte. Ltd. · Dimensions: 39 x 10 x 1 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08885013200577), received between Oct 16, 2024 and Oct 16, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).
1 other recall cover devices cleared under the same FDA submission (K051093); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Appears to Trigger Rejection1
Patient problems
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAD BEEN IMPLANTED FOR A PERIOD OF APPROXIMATELY 9 MONTHS BEFORE IT WAS REPORTED ON (B)(6) 2023 THAT PATIENT EXPERIENCED SWELLING, SORENESS, PAIN AND FLUID ACCUMULATION. ON (B)(6) 2024, REVISION SURGERY WAS PERFORMED TO REMOVE THE DEVICE. DURING REMOVAL OF DEVICE, THE SURGEON REPORTED THAT DEVICE HAD SHOWED SIGNS OF INTEGRATION WITH SURROUNDING SOFT TISSUE. ADDITIONALLY, WITH USE OF ENDOSCOPE, A SMALL BUMP COULD BE OBSERVED IN THE RIGHT NOSTRIL, NONE OBSERVED IN THE LEFT NOSTRIL. COLOURLESS FLUID OBSERVED AFTER CUTTING INTO BUMP. NO CLEAR SIGNS INDICATING PRESENCE OF INFECTION REPORTED BY THE SURGEON. CURRENTLY, THE PATIENT IS RECOVERING WELL WITH NO MORE COMPLAINTS OF PAIN. THIS COMPLAINT IS ASSOCIATED WITH THE SECOND OF 2 DEVICES IMPLANTED IN THIS PATIENT. REFER TO MEDWATCH 3007303685-2024-00001 FOR THE FIRST DEVICE IMPLANTED IN THIS PATIENT.
Patient problems: Swelling/ Edema
MAUDE report 20459677 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K051093. One submission often covers many models, so check the product and lot details in each record.
- Z-0446-2012 · Apr 27, 2011 · TerminatedOsteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.
Other Methyl Methacrylate For Cranioplasty devices
- Direct Inject 79-45905Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY1 recall7 reports
- CRANIOS Reinforced 615.05.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY17 reports
- CRANIOS Reinforced 615.10.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY11 reports
- Direct Inject 79-45910Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY7 reports
- HYDROSET 79-43910Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY4 reports
- CRANIOS Reinforced 615.03.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY4 reports
- StaGraft DBM Putty 92-2004Biomet Orthopedics, LLC · Methyl Methacrylate For Cranioplasty3 reports
- HYDROSET 79-43905Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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